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Recall Observatory FDA recall evidence

Device product

TDWorkstation version 11.01.A or higher. TDWorkstation Evolution. TDWorkstation receives patient results from a connected instrument and sends them to a Laboratory Information System (LIS).

Z-1310-2014

February 17, 2014

Class III

Product summary

Firm
Technidata S.A.
Event
Event 67628
Status
Terminated
Classification
Class III
Quantity
85 units total (1 unit in US)
Official record key
device-enforcement:Z-1310-2014

Official wording

Reason: If a conflict occurs between a Demography Query and a Result Transmission by the instrument, the TDWorkstation could send an incorrect patient demography to an instrument.

Code information: version 11.01.A or higher

Distribution pattern: Distributed in the state of PA.

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

    If a conflict occurs between a Demography Query and a Result Transmission by the instrument, the TDWorkstation could send an incorrect patient demography to an instrument.